LiverPRIMEi & LiverPRIMEii

• Research type

  Research Study

• Full title

  Short Term Pre-Operative Dietary Intervention to Reduce Intra-Hepatic Fat before Resection of Metachronous Colorectal Liver Metastases: a four phase research programme (LiverPRIME)\n\n\nLiverPRIMEi: A Precision and Reproducibility Assessment of the Quantification of Intra-Hepatic Fat by Chemical Shift Magnetic Resonance\n\nLiverPRIMEii: Assessment of Natural Progression of Iatrogenic Changes in Intra-Hepatic Fat Following Cessation of Neoadjuvant Chemotherapy for Colorectal Liver Metastases

• IRAS ID

  196999

• Contact name

  Daren Subar

• Sponsor organisation

  East Lancashire Hospitals NHS trust

• Duration of Study in the UK

  0 years, 9 months, 29 days

• Research summary

  Background\n\nLiver fat is a risk factor for higher rates of complications and death after liver surgery to remove colorectal liver metastastates(CRLM). Liver fat may be associated with high levels of body fat, high sugar diets or chemotherapy before surgery. \n\nDietary interventions have been shown to successfully reduce liver fat within the time frame available pre-operatively in overweight patients but no studies have examined this in livers with CRLM. \n\nFurthermore, there is no evidence demonstrating the natural progression of chemotherapy asociated liver fat following its completion.\n\nLastly, chemical shift magnetic resonance (CS-MR) is a new method of measuring liver fat that has been proposed to identify this risk factor.\n\nAims\n\nLiverPRIMEi\nTo assess the accuracy & reproducibility of CS-MR measurements of liver fat using scanner at RBH.\n\nLiverPRIMEii\nTo identify changes in chemotherapy associated liver fat using CS-MR over 4 weeks after completion of pre-operative chemotherapy for CRLM.\n\nLater phases of this research stream will assess the effictiveness and safety of a pre-operative diet to reduce liver fat.\n\nParticipants\n\nLiverPRIMEi\nParticipants >18 yo with BMI >25.\n\nLiverPRIMEii\nPatients >18 yo with CRLM who have received pre-operative chemotherapy.\n\nDesign\n\nSingle centre cohort studies at Royal Blackburn Hospital.\n\nParticipants will require 2 CS-MR scans at least 1 day apart. The scans will be analysed for agreement.\n\nPatients will undergo CS-MR at cessation of chemotherapy and 4 weeks later and assessed for difference; blood tests for liver function will be acquired on both visits.\n\nOutcomes\n \nLiverPRIMEi\nCS-MR potentially offers an easier mechanism of non-invasively measuring liver fat than current gold standard. \n\nLiverPRIMEii\nKnowledge of the natural progression of chemotherapy associated liver fat will inform us of the need for pre-operative liver fat reduction within this group.\n\n

• REC name

  North West - Preston Research Ethics Committee

• REC reference

  16/NW/0416

• Date of REC Opinion

  21 Jun 2016

• REC opinion

  Further Information Favourable Opinion